Investigating a new imaging tracer for diagnosing giant cell arteritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label clinical trial aims to evaluate the efficacy of AzaFol-PET/CT imaging in diagnosing giant cell arteritis (GCA) compared to the standard 2-[18F]FDG-PET/CT. The study will assess the safety and tolerability of AzaFol in patients with suspected GCA. Participants aged 50 and older will undergo imaging at a single timepoint to determine the tracer's ability to distinguish between vasculitic and atherosclerotic lesions. The hypothesis is that AzaFol, which targets activated macrophages, will provide more accurate diagnostic information than the current standard.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals ≥ 50 years with clinical suspicion of GCA
* Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit
* Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
* Are willing and able to comply with procedures required in this protocol.

Exclusion Criteria:

1. Folate deficiency
2. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug
3. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed)
4. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\[18F\]FDG tracer application
5. Glucose level \> 10 mmol/l at the timepoint of 2-\[18F\]FDG PET/CT
6. Unable to remain in the PET/CT for the duration of the examination
7. Unable to lie still for the duration of the examination (45 min)
8. Unable not to eat or drink (except water) for 6 hours prior to 2-\[18F\]FDG tracer application
9. Prior PET-imaging within 60 days before baseline
10. Intake of vitamin supplements containing \> 1mg/day folic acid within 48 h prior to the PET/CT with AzaFol
11. Known hypersensitivity or allergy to folic acid
12. Enrolment of the investigator, his/her family members, employees and other dependent persons
13. Participation in another study with investigational drug within the 7 days preceding and during the present study.

Where it's running

• Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Britta Maurer — Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
• Study coordinator: Britta Maurer
• Email: RI-Studien@insel.ch
• Phone: +41 31 63 2 7229

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.